# K102461: Fractora

- Pathway: 510(k) (Traditional)
- Applicant: Invasix, Ltd.
- Decided: Jun 2, 2011 after 279 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K943450 (1995). 224 ancestors in all.
24 later devices descend from it; 4 cite it directly.
0 of 249 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073572: Matrix RF Applicator, Syneron Medical, Ltd. (2008) Summary page 1.

## Most influential descendants
- K150161: Venus Viva SR Device (2015), 9 descendants of its own
- K131758: Surgen U (2013), 5 descendants of its own
- K203299: CellFX System (2021), 4 descendants of its own
- K171359: Pollogen Legend+ System (2017), 4 descendants of its own
- K211444: CellFX System (2021), 3 descendants of its own

## Indications for use
Fractora is intended for dermatological procedures requiring ablation and resurfacing of the skin.

Source page: https://510kreport.com/device/K102461
Methodology: https://510kreport.com/methodology